ImClone Systems LLC
Form 483 issued July 27, 2023 · Branchburg, New Jersey
- Inspection
- Jul 10 – Jul 27, 2023
- Investigators
- Samuel Mindaye· Thuy T. Nguyen
- Observations
- 8
- Pages
- 5
- FEI number
- 3002889358
In short: On July 27, 2023, FDA issued a Form 483 with 8 observations to ImClone Systems LLC in Branchburg, New Jersey (FEI 3002889358) after an inspection that ran Jul 10 – Jul 27, 2023. The investigators were Samuel Mindaye and Thuy T. Nguyen. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 211.160 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
QC sample tracking, handling, and inventory management are inadequate to ensure sample…
- 02
Management of Empower and Softmax Pro…
- 03
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its…
- 04
Oversight of personnel training in support of manufacturing and…
This inspection in context
Samuel Mindaye
1 document · 2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New Jersey.
The firmImClone Systems LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ImClone Systems LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected ImClone Systems LLC?
Samuel Mindaye and Thuy T. Nguyen are named on this Form 483, for the inspection of Jul 10 – Jul 27, 2023. Each investigator has a profile showing what they cite most.
When was ImClone Systems LLC inspected by FDA?
The inspection ran Jul 10 – Jul 27, 2023, and the Form 483 is dated July 27, 2023.
How do I get the full Form 483 for ImClone Systems LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.